Biosimilars: Policy, Practice, and Post Marketing Surveillance to Support Treatment and Coverage Decisions - DEC. 15-16, 2020 | VIRTUAL - AMCP
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PA R T N E R S H I P
FORUM
No. 3 2020
Biosimilars: Policy, Practice, and
Post Marketing Surveillance to Support
Treatment and Coverage Decisions
DEC. 15–16, 2020 | VIRTUAL
as of Jan. 4, 2021
BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS
WELCOME
Welcome to AMCP’s final Partnership Forum of 2020. We appreciate that you will be spending the next
two days with us to identify key actions that can support the further development and use of biosimilars
in the U.S. health care system.
Biologics, including biosimilars, offer a critical opportunity for expanding patient access to medicines
while simultaneously reducing health care costs through a competitive marketplace. However, biosimilar
adoption in the United States is significantly slower than in other countries.
AMCP’s focus is on addressing the practice and regulatory hurdles that hinder utilization of biosimilars
and ensuring health care decision makers have the evidence they need to evaluate the safety and
effectiveness of these therapies.
During this AMCP Partnership Forum, we will discuss the policy, practice, and post-marketing
surveillance activities that support treatment and coverage decisions for biosimilars. We will also analyze
the barriers to biosimilar adoption, including gaps in provider knowledge and the need to generate
more real-world evidence to inform treatment and coverage decisions.
To facilitate a successful dialogue, I am pleased to welcome a variety of participants to this AMCP
Partnership Forum, including payers, pharmacists, integrated delivery system leaders, health economists
and analysts, academicians, patient care providers, pharmaceutical manufacturers, and other key
decision makers.
This AMCP Partnership Forum would not be possible without the generous support of our sponsors:
Amgen, the Association for Accessible Medicines, Boehringer Ingelheim, Fresenius Kabi, Johnson &
Johnson, Novo Nordisk, Pfizer, Sandoz, and Takeda.
Following this event, AMCP will produce proceedings documenting our findings and recommendations
in an upcoming issue of AMCP’s Journal of Managed Care + Specialty Pharmacy, which is widely
disseminated to decision makers around the country.
I look forward to your participation in this important AMCP Partnership Forum.
Sincerely,
Susan A. Cantrell, RPh, CAE
AMCP CEO
BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS
MODERATOR
Clifford Goodman, PhD
Senior Vice President
The Lewin Group
Clifford Goodman, PhD, is a senior vice president at The Lewin Group. He has 30 years of
experience in health technology assessment, evidence-based health care, health economics,
and aspects of health care innovation, regulation, and payment. Dr. Goodman often serves as a
health policy issues moderator and facilitator of expert panels and advisory boards. He served
as chair of the CMS Medicare Evidence Development & Coverage Advisory Committee and
president of the professional society, Health Technology Assessment International. He received
his Doctorate in Philosophy from The Wharton School of the University of Pennsylvania and
degrees from Georgia Tech and Cornell.
AMCP PARTNERSHIP FORUM | DEC. 2020 PAGE 1
BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS
AGENDA
TUESDAY, DEC. 15
12-5pm ET Welcome and introductions
Presentation: Perspectives on biosimilars
Panel discussion: Exploring the challenges and facts about biologics and
biosimilars in the United States
Breakout session 1: Strategies and messaging to increase access and
adoption of biosimilars
Report out and discussion
HOSTED BY AMCP IN PARTNERSHIP WITH
PAGE 2 AMCP PARTNERSHIP FORUM | DEC. 2020
BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS
AGENDA
WEDNESDAY, DEC. 16
12-5pm ET Welcome and day 1 debrief
Panel discussion: What is working in the world of biosimilars?
Breakout session 2: Strategies and real-world evidence needs and opportunities
to help with biosimilar adoption
Report out and discussion
Forum summary and close
AMCP PARTNERSHIP FORUM | DEC. 2020 PAGE 3
BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS
PARTICIPANTS
Christina Barrington, RPh, Diana Brixner, RPh, PhD, Mary Jo Carden, JD
PharmD FAMCP Head of Policy
Sandoz
Vice President of Pharmacy Programs Professor
Priority Health Department of Pharmacotherapy
Mary Jo Carden, JD, serves as the head
Christina Barrington, RPh, PharmD, has Diana Brixner, RPh, PhD, FAMCP, is the of policy for Sandoz. She joined Sandoz
more than 20 years of managed care executive director at the University in Sep. 2019 after serving in various
experience and is currently the vice of Utah Pharmacotherapy Outcomes capacities at AMCP for six years, including
president of pharmacy programs for Research Center. She is also a research as vice president of government and
Priority Health, where she is responsible associate at the Institute of Public pharmacy affairs. She also has experience
for setting strategy for the pharmacy Health, Medical Decision Making, and in policy and government affairs in PBMs,
department and managing the Health Technology Assessment in the retail pharmacies, and long-term care
pharmaceutical services budget across Department of Public Health and Health pharmacies. She holds a Bachelor of
the organization. In addition to her role Technology Assessment at University Science from University of Pittsburgh
in pharmacy management, Dr. Barrington of Miami Information Technology. Her and a Juris Doctor degree from Catholic
has conducted extensive research appointment supports her international University in Washington, D.C.
into the impact of value-based benefit collaborations in oncology research,
designs and is a pioneer in risk-based personalized medicine, and value
contracting strategies. She has presented assessment. Dr. Brixner is a founding
her research and innovative contracting member of the Health Policy and Science
strategies at a variety of conferences. Council, where she also served on the
Additionally, she has served as the vice- executive board. She is also a past
chairman of the board of managers for president of the International Society
the Illinois Foundation of Quality Health of Pharmacoeconomics and Outcomes
Care and is currently a member of the Research. Dr. Brixner is a long-standing
URAC Measures Advisory Research member and past president of AMCP.
Group. As an active member of AMCP She currently serves as a director on
since 1996, Dr. Barrington has held the the board for the Biologics & Biosimilars
office of president of the Midwest affiliate Collective Intelligence Consortium (BBCIC).
for two terms and currently serves on the
finance committee.
PAGE 4 AMCP PARTNERSHIP FORUM | DEC. 2020
BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS
PARTICIPANTS
Jack Cox Joe Eggler Erika Emerson
Senior Director Senior Director, Market Access Executive Director
Nova Nordisk Inc. Account Management Diabetes Leadership Council
Fresenius Kabi
Jack Cox is a senior director of market Erika B. Emerson is executive director
Joe Eggler has 30 years of health care
access and trade strategy at Novo of the Diabetes Leadership Council. She
experience in both pharmaceutical and
Nordisk. Jack as more than 30 years has more than 20 years of health policy
molecular diagnostics. During this time,
experience in pharmaceutical, biotech, and advocacy experience, including
he has held positions ranging from sales,
and distribution channels and has worked health care and pharmaceutical public
marketing, new product development,
in marketing, operations, business policy, issues management, strategic
sales management, payer account
development, and market access. He communications, and stakeholder
management, executive level commercial
joined Novo Nordisk in 2012 and is relations. Her pharmaceutical industry
operations, market access, and patient
currently responsible for payer marketing experience and knowledge of the U.S.
and provider support programs. He has
and pricing/contracting strategy for the health care system lend unique insight
worked in various companies starting
insulin and biopharm franchise teams. on state and federal policies impacting
with TAP pharmaceuticals, Prometheus
Prior to joining Novo Nordisk, he worked access, quality and value of care and
Laboratories, Provista Diagnostics, Lash
at Accredo Specialty Pharmacy as vice coverage for people with chronic
Group, and Fresenius Kabi. Joe is currently
president, business development where conditions. Erika holds a Masters in Public
the senior director, payer account
he led the strategy development for Policy from the Harvard Kennedy School
management at Fresenius Kabi and leads
pipeline products, managed manufacturer and a bachelor’s degree in journalism and
the team that prepares the launch of
relations, and contract negotiations. He political science from the University of
several biosimilars.
earned his Bachelor of Science from Wisconsin-Madison.
Bowling Green State University and his
Master in Business Administration from
Marshall University.
AMCP PARTNERSHIP FORUM | DEC. 2020 PAGE 5
BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS
PARTICIPANTS
Alison Falb, JD Anna Hyde Jim Kenney, RPh, MBA
Regulatory Counsel Vice President of Advocacy and Access President
FDA Arthritis Foundation JTKENNEY LLC
Alison Falb, JD, is a regulatory counsel in Anna Hyde is the vice president of Jim Kenney, RPh, MBA, is founder
the FDA Center for Drug Evaluation and advocacy and access at the Arthritis and president of JTKENNEY LLC, a
Research’s (CDER) Office of Therapeutic Foundation. She oversees grassroots managed care pharmacy consulting
Biologics and Biosimilars, which oversees engagement and both the federal and practice in Waltham, Mass. Jim worked
the development and implementation state legislative programs. Her focus is to for Harvard Pilgrim Health Care for 38
of regulatory policy related to biosimilar, raise the visibility of arthritis as a public years in pharmacy management, most
interchangeable, or other therapeutic health priority; build support for federal recently as the manager of specialty
biologic products. Prior to joining the and state legislation that ensures access and pharmacy contracts. Jim has
Office of Therapeutic Biologics and to affordable, high-quality health care; received national recognition for the
Biosimilars, Alison was a senior advisor and enhance patient engagement in the development of value and outcomes-
at the Center for Medicare and Medicaid policy-making process. Anna worked as based contracts for pharmacy and
Innovation at CMS where she led senior manager for federal affairs at the medical products. Jim is a pharmacy
policy development for specialty care American Congress of Obstetricians and preceptor for the Massachusetts
and episode-based payment models Gynecologists. She began her health College of Pharmacy and Health
under the Medicare Access and CHIP policy career as a congressional fellow Sciences. He currently serves on the
Reauthorization Act of 2015 statute and for Energy and Commerce Committee Massachusetts Pharmacists Association
designed and implemented alternative members, where she drafted legislation Government and Legislative Affairs
payment models including the Oncology and staffed committee activities. Anna Committee. Jim is currently immediate
Care Model. received a Bachelor of Arts in history past-president of AMCP, where he has
from Southern Methodist University and been an active member for 30 years
Master in Arts in political science from and has served on several committees.
American University.
PAGE 6 AMCP PARTNERSHIP FORUM | DEC. 2020
BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS
PARTICIPANTS
Troy Koch, PharmD, MBA April Kunze, PharmD Paul Lakomski, BS,
Account Medical Lead Senior Director, Clinical Formulary RPh, MBA
Takeda Pharmaceuticals Development and Trend Management
Pharmacy Services Manager
Strategy
Aetna / CVS
Prime Therapeutics
Troy Koch, PharmD, MBA, is currently
a director, account medical lead for Paul G. Lakomski, RPh MBA, is a pharmacy
April Kunze, PharmD, is the senior
Takeda Pharmaceuticals. In his role, he services manager for Aetna/ CVS. In
director of formulary development and
engages in scientific exchange regarding this role, he supports Aetna’s clients in
trend management strategy at Prime
Takeda products with some of the top trend management, clinical programs,
Therapeutics (Prime) and is responsible
corporate and national health plan and and benefit design for pharmacy.
for evaluating and communicating clinical
PBMs. Dr. Koch has an extensive career Previously, Paul was a director of account
and financial decision making models
in the pharmaceutical and managed care management-MCO for Catamaran;
for multiple formularies. She leads trend
industries, holding positions previously pharmacy director for Empire Blue Cross
management activities and analyzes the
with Humana, Medimpact, and Hobart Blue Shield and Anthem New Hampshire;
value of formulary changes, utilization
Core (now Precision for Value). He director account management regional
management, and other clinical programs.
earned a Doctor of Pharmacy degree for WellPoint NextRx; drug utilization
She also oversees Prime’s pipeline division
from the University of Kentucky, a Master review director, pharmacy director, and
and proactively develops strategies to
of Business Administration from the director of network management for
manage new, high-cost drug approvals.
University of Louisville, and completed a Excellus Blue Cross Blue Shield. He is as
Prior to joining Prime in 2004, Dr. Kunze
residency in managed care pharmacy with subject matter expert regarding clinical
worked for a home infusion company
Humana Inc. programs, pharmacy cost drivers, trends,
where she gained insights to many specialty
and pharmacy/ medical benefit products.
drugs and disease states. She also acquired
expertise in clinical patient management.
AMCP PARTNERSHIP FORUM | DEC. 2020 PAGE 7
BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS
PARTICIPANTS
Jeffrey (Jeff) Larson, RPh, Molly Billstein Leber, Hannah Lynch, MPS
MS, MBA PharmD, BCPS, FASHP Associate Director, Federal Government
Relations and Health Policy
Clinical Director Associate Director, Drug Use Policy and
National Psoriasis Foundation (NPF)
CVS Health Formulary Management
Yale New Haven Health
Hannah Lynch, MPS, is the associate
Jeff Larson, RPh, MS, MBA, is a clinical
Molly Billstein Leber, PharmD, MBA, director of federal government relations
director and supervises a team of clinical
BCPS, FASHP, is the associate director and health policy for NPF. In this role, she
advisors who are responsible for the
of drug use policy and formulary directs NPF’s legislative and regulatory
clinical programs and clinical management
management at Yale New Haven Health efforts at the federal level, develops the
services provided to CVS Health clients
System. In this role, she is responsible foundation’s federal policy positions,
in the health plan market segment. Jeff
for standardizing safe and cost-effective and represents NPF on several national
joined CVS Health in 1994 and is currently
medication therapy across the system. coalitions. Prior to her current role, she
based in Minneapolis. Prior to joining
worked for the Biotechnology Innovation
the company, Mr. Larson completed a
Organization (BIO) as manager of health
two-year management residency at the VA
care policy and research, focusing
Medical Center, Minneapolis concurrent
primarily on Medicare, Medicaid, and
with graduate work at the University of
drug reimbursement policy. She also
Minnesota. Jeff earned his Bachelor of
spent time with the National Alliance of
Science in pharmacy from North Dakota
State Health CO-OPs and on Capitol Hill.
State University, his Master of Science in
Hannah received a Master of Professional
hospital pharmacy from the University
Studies in legislative affairs from The
of Minnesota, and a Master in Business
George Washington University, and a
Administration from the University of
Bachelor of Science in political science
St. Thomas. He is an active member of
(pre-law) from The University of North
AMCP and has served on multiple AMCP
Carolina at Greensboro.
committees, including former committee
leadership positions.
PAGE 8 AMCP PARTNERSHIP FORUM | DEC. 2020BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS
PARTICIPANTS
George Mayzell, MD, MBA Dorothy McCabe, PhD, FCP Corey McEwen, PharmD, MS
President Executive Director, CDMA, Specialty Care Director, Oncology Pharmacy Services
Empowered Healthcare Boehringer Ingelheim Pharmaceuticals Inc. Massachusetts General Hospital
George Mayzell, MD, MBA, is the founder Dorothy McCabe, PhD, FCP, is executive Corey McEwen, PharmD, MS, is the
and president of Empowered Healthcare, director of clinical development director of oncology pharmacy services
which specializes in population health, and medical affairs, specialty care at Massachusetts General Hospital.
care management redesign, clinical organization at Boehringer Ingelheim In this role, he oversees clinical and
variation, and clinical integration. Dr. Pharmaceuticals. She provides medical/ operational pharmacy services for the
Mayzell was the past chief clinical scientific, technical, and strategic oncology pharmacy service line including
officer of Vizient Southeast and senior directions to the plans, programs, and inpatient oncology pharmacy, the
vice president/chief medical officer procedures within the inflammation main campus infusion center, and two
and chief clinical integration officer for therapeutic and indication areas with regional infusion centers in the greater
AMITA Health. AMITA Health is a joint a focus on biosimilar development. Boston area. Additionally, Dr. McEwen
operating company formed in Feb. 2015 She has over 35 years experience has oversight of the pharmacy clinical
by Adventist Midwest Health and Alexian leading product development and trials programs which support the largest
Brothers Health System, encompassing innovation in both small-molecule and hospital-based research program in
nine hospitals and an extensive physician biological compounds. Dr. McCabe the country. He completed his two-year
provider network of more than 3,000 has broad multidisciplinary science health system pharmacy administration
physicians. Dr. Mayzell joined Adventist and medicine expertise. She has held residency at the Cleveland Clinic in
Midwest Health in Jan. 2013 after serving leadership positions in medical affairs Cleveland. He received Master of
as CEO of Health Choice and senior and new product development at Science in health system pharmacy
vice president of Methodist Le Bonheur several pharmaceutical companies and administration from Northeast Ohio
Healthcare in Memphis, Tenn. He received has been involved in many regulatory Medical University and received his
his medical degree from Rutgers and his interactions and strategies leading to Doctor of Pharmacy from the University
Master in Business Administration from commercial success. of Mississippi.
Jacksonville University.
AMCP PARTNERSHIP FORUM | DEC. 2020 PAGE 9BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS
PARTICIPANTS
Ann McNamara, PharmD Therese Mulvey, MD, FASCO Farhana Naz, BS
Director of Clinical Development Director Quality Safety and Value Senior Director Strategy
Fairview MGH Cancer Center Fresenius Kabi
MGH
Ann McNamara, PharmD, is director of Farhana Naz, BS, has more 25 years of
Therese Mulvey, MD, FASCO, is a medical
clinical development within the specialty experience in the health care industry
oncologist specializing in breast cancer at
development team at Fairview Specialty analyzing evidence and cost value
Massachusetts General Hospital (MGH).
Pharmacy. Dr. McNamara has worked at propositions for drug coverage decisions.
She is the director of quality, safety, and
Fairview Specialty Pharmacy since Sep. Her experience includes pharmaceutical
value for the cancer center and its nine
2004. She is responsible for the direction product strategy support at Anthem,
affiliated network sites. She recently
and oversight of clinical development, Express Scripts, Aetna, Cardinal Health,
co-chaired the MGH Oncology Pharmacy
therapy management, adherence and Proctor & Gamble pharmaceuticals.
and Therapeutics Safey Committee
programs, waste management strategies,
(PTSC) and serves on the MGH Brigham
clinical reporting, and specialty pipeline
Oncology PTSC. Dr. Mulvey is an active
monitoring. She provides clinical support
volunteer for the American Society of
for payer strategies, payer quarterly
Clinical Oncologists, where she currently
business reviews, and manufacturer
serves as the immediate past chair of its
initiatives. Prior to her current position,
quality-of-care council and is a member of
she was the director of the clinical
the telehealth task force. She is the author
specialist team at Express Scripts. She
of many papers concerning care delivery
received her Doctor of Pharmacy at the
and improving cancer care.
University of Minnesota and completed an
ambulatory residency at St. Paul Ramsey
Medical Center.
P A G E 10 AMCP PARTNERSHIP FORUM | DEC. 2020BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS
PARTICIPANTS
Sonia Oskouei, PharmD, Gary Owens, MD Chad Pettit, MBA
BCMAS, DPLA President Executive Director, Marketing
Gary Owens Associates Amgen
Vice President, Biosimilars
Cardinal Health
Gary Owens, MD, was actively involved Chad Pettit, MBA is the executive
Sonia T. Oskouei, PharmD, BCMAS, in the managed care movement of the director of marketing for Amgen’s
DPLA, serves as the vice president of 1990s, which evolved to the current era biosimilars business unit and leads the
biosimilars for Cardinal Health, where of health care coverage and payment global biosimilars commercial team
she leads the organization’s biosimilar reform. Dr. Owens served as the vice in developing global launch strategy
strategy. Previously, Dr. Oskouei served president of medical management and for Amgen’s portfolio of biosimilar
as vice president of innovation and policy at Independence Blue Cross for medicines. He serves as a liaison with
digital health at Premier Inc. and led the 22 years. Forming his own consulting the biopharmaceutical industry on policy
national biosimilars strategy on behalf of practice in 2007, Dr. Owens provides matters in biosimilars, a rapidly growing
4,000 hospitals and more than 175,000 strategic and tactical consulting services segment of the Amgen business. With
other provider types. Prior to her work at to a wide range of clients, including his global experience, Chad has broad
Premier, Dr. Oskouei oversaw pharmacy pharmaceutical manufacturers, device perspective and is recognized as an
purchasing and procurement at Novant manufacturers, and other developers expert on biosimilar commercialization,
Health, a four-state integrated delivery of new technology. Dr. Owens is the market access for biosimilars, and the
network. She received her Doctor of past chair of the Arthritis Foundation policy measures required to facilitate
Pharmacy from Belmont University, and of Eastern Pennsylvania, where he was cost savings for patients and the
completed post-graduate residencies a former member of the foundation’s health care system over the long run.
in clinical pharmacy and health system northeast regional board of directors. Chad received his Master in Business
pharmacy administration. In addition. Dr. Owens was the first Administration from the University of
physician to serve as a board member California Los Angeles, Anderson School
for AMCP from 2014 to 2018. of Management, and holds a Bachelor of
Science in chemical engineering from the
University of California Davis.
AMCP PARTNERSHIP FORUM | DEC. 2020 P A G E 11BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS
AA
P GR
ETNID
CAIPANTS
Laura Pizzi, PharmD, MPH Ronald Piervincenzi, PhD Jim Rebello
Director and Professor Chief Executive Officer Vice President, Formulary Strategy
Rutgers University—Health Outcomes, Policy, United States Pharmacopeia (USP) Magellan Rx Management
and Economics (HOPE) Program
Ronald T. Piervincenzi, PhD, has served Jim Rebello is currently the vice president
Laura Pizzi, PharmD, MPH, is a seasoned
as chief executive officer of USP since of formulary strategy for Magellan Rx
evaluation scientist and professor and
2014. Under his leadership, USP has Management underneath the MRx
director of the Center for Health Outcomes,
modernized its operations and launched Specialty division. He works with payers to
Policy, and Economics at Rutgers University.
innovative new science, including in digital provide valuable solutions for formulary
She has led interdisciplinary teams to
medicine, cutting-edge manufacturing management to find savings in the high-
develop and conduct cost and outcome
technologies, and advanced biologics. trending specialty space on both the
analyses on pharmacological therapies as
Before joining USP, Dr. Piervincenzi served pharmacy and medical benefits. Jim is a
well as a variety of non-pharmacological
as vice president of development sciences pharmacist with more than a decade of
interventions. She has testified before
with Biogen Idec Inc. and was a partner managed care experience working directly
the U.S. House of Representatives
and leader in McKinsey & Company’s with health plans and employers. Jim
Committee on Ways and Means on
global pharmaceutical and medical received his Doctor of Pharmacy at the
Medicare overspending in beneficiaries
products practice for more than 12 years. University of Rhode Island and also served
with end-stage renal disease. Dr. Pizzi is
Dr. Piervincenzi earned his Doctorate in the U.S. Air Force.
editor in chief of Value and Outcomes
in Philosophy and Master of Science
spotlight, member of the editorial board
from Duke University in biomedical
for PharmacoEconomics, deputy editor
engineering, with research focused on
of American Health and Drug Benefits,
protein engineering.
co-chair of the Cross-Council Workgroup
on Competencies for New Professionals in
Health Economics and Outcomes Research,
and chair of the Common Economic
Measures Workgroup for a new CDC-
funded multi-center grant on glaucoma.
P A G E 12 AMCP PARTNERSHIP FORUM | DEC. 2020BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS
PARTIC
A IGPEANNDT A
S
Carly Rodriguez, PharmD, Elizabeth Sampsel, PharmD, Marissa Schlaifer, MS, RPh
FAMCP MBA, BCPS Vice President, Policy and Regulatory Affairs
OptumRx
Pharmacy Director, Clinical Innovation Clinical Program Manager
Moda Health MedImpact Healthcare Systems Inc.
Marissa Schlaifer, MS, RPh, currently
Carly Rodriguez, PharmD, FAMCP, is Elizabeth Sampsel, PharmD, MBA, BCPS, serves as vice president, policy and
pharmacy director, clinical innovation provides clinical consultative services regulatory affairs at OptumRx, where
for Moda Health. She provides for MedImpact to health plans, including she’s responsible for public policy related
strategic leadership for clinical P&T support and quality measure to OptumRx’s PBM and home delivery,
initiatives, operations, innovation, and optimization to assist clients with achieving specialty, home infusion, compounding,
the integration and management of overall improved health outcomes at the and community mental health
medications across pharmacy and lowest possible net cost. Dr. Sampsel pharmacies. Prior to her current position,
medical benefits. Her areas of expertise has supported clients over numerous she worked as an independent consultant
include formulary management, cost- lines of business, including commercial, focused on health care policy analysis,
savings and utilization management government programs, and employer issue advocacy, practice advancement
strategies, specialty drug management, groups. Dr. Sampsel has more than and business development. Previously,
benefit design, and medical pharmacy. 20 years of pharmacist experience in Marissa served as the head of policy in
She has presented to a variety of various settings, including PBM, health the government affairs department for
audiences on important topics in plan, and health systems and with the a major PBM and pharmacy innovation
managed care, such as specialty FormularyDecisions platform. She currently company, and as director of pharmacy
pharmacy, data integration, oncology, serves on the AMCP legislative and and regulatory affairs at AMCP. Marissa
and trend management. Dr. Rodriguez regulatory advisory committee, leads the currently serves as AMCP President.
received her Doctor of Pharmacy from COVID-19 subcommittee, and has been a
the University of Washington, School national judge for the AMCP Foundation
of Pharmacy, along with a certificate in P&T Competition for 10 years.
biomedical and regulatory affairs. She was
recognized as a fellow of AMCPin 2019 for
exceptional contribution, commitment,
and sustained excellence in managed
care pharmacy.
AMCP PARTNERSHIP FORUM | DEC. 2020 P A G E 13BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS
PARTICIPANTS
Christine Simmon, JD Eva Temkin, JD Jaap Venema, PhD
Senior Vice President, Policy and Strategic Acting Director for Policy Executive Vice President and
Alliances and Executive Director, FDA, CDER, Office of Therapeutics Chief Science Officer
Biosimilars Council and Biologics USP
Association for Accessible Medicines (AAM)
Eva Temkin, JD, is the acting director Jaap Venema, PhD, is the executive vice
Christine Simmon, JD, joined the
for policy in the FDA CDER’s Office of president and chief science officer for
Association for Accessible Medicines
Therapeutics and Biologics. She oversees USP, where he leads the organization’s
in 2012 as the senior vice president of
the development and implementation scientific strategy and development of
policy and strategic alliances and most
of policy related biological products. Eva quality standards for medicines, dietary
recently was named executive director
leads FDA’s Biosimilar Action Plan, which supplements, food ingredients, and
of AAM’s Biosimilars Council, which was
outlines the administration’s plans for health care practice. Dr. Venema oversees
founded in 2015. Christine is responsible
encouraging innovation and competition implementation of the USP Science
for leading policy development and
among biologics and the development Quality Framework, which grounds quality
issues management for AAM, directing
of biosimilars. She also works on patient standards development in pharmaceutical
the Biosimilars Council, and building
access. Previously, Eva was associate chief science to increase public trust in
relationships with strategic partners in
counsel for drugs in FDA’s Office of Chief medicines. He guides exploration of
the health care sector, including patient
Counsel and counseled on numerous emerging technologies that may inform
advocacy groups. Christine previously
biomedical products issues, including future quality standards; serves as chair
served as vice president of policy, public
expedited pathways, data development of USP’s council of experts; and oversees
affairs and development at AAM from
questions, and evidentiary standards to collaborations with other pharmacopeial
2002 to 2006. Before rejoining the
over-the-counter monograph reform. Eva and scientific groups. Dr. Venema
association, she was the senior director
was a former litigator at Cravath, Swaine & previously served in scientific leadership
of public policy for CVS Caremark, where
Moore LLP and Robbins, Russell, Englert, positions at Solvay and AbbVie (formerly
she was the policy lead for the integrated
Orseck, Untereiner & Sauber LLP. She was Abbott Laboratories). Dr. Venema earned
retail, convenient care clinic, and
also a law clerk in the U.S. District Court a master’s degree in chemistry from the
pharmacy benefit manager enterprise at
for the Eastern District of New York. Free University of Amsterdam, and a
both the state and federal levels.
Doctorate of Philosophy in biochemistry
and molecular biology from Leiden
University in the Netherlands.
P A G E 14 AMCP PARTNERSHIP FORUM | DEC. 2020BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS
PARTICIPANTS
Randy Vogenberg, Erin Wright, PharmD, BCPS
PhD, RPh Director, Field Pharmacy
Premier Inc.
Principal and Board Chair
Institute for Integrated Healthcare (IIH) and
Employer-Provider Interface Council (EPIC) Erin Wright, PharmD, BCPS, is a director
with the field pharmacy team at Premier
Randy Vogenberg, PhD, RPh, is principal
Inc. She is responsible for providing
of IIH. Previously, he was the senior vice
expertise regarding Premier’s service and
president and thought leader for Aon
contract portfolios to Premier members
Consulting North America. He currently
and serves as the primary liaison on all
serves as board chair for the EPIC
pharmacy-specific initiatives. Dr. Wright
for the Hospital Quality Foundation;
serves Premier’s field team as the clinical
co-leader for the National Employer
resource on biosimilars. She was a clinical
Biologics & Specialty Initiative, Midwest
and operations coordinator at a large
Business Group on Health; and fellow
academic medical center for 14 years
for the Foundation for HealthSmart
before joining Premier in December
Consumers. His work for self-funded
2019. Dr. Wright received her Doctor of
employers include innovative contracting,
Pharmacy from Purdue University and
compliance, and holistic care cost
she is an active member of the American
management or research to drive high
Society of Health System Pharmacists
performing plans. His expertise in
as well as the Florida Society of Health
commercial/employer benefits and care
System Pharmacists.
delivery issues has produced several
books, publications, and presentations
in peer-reviewed and non-peer reviewed
venues. He continues collaborations
with various universities, including three
adjunct faculty appointments and guest
lectureships on his areas of expertise.
AMCP PARTNERSHIP FORUM | DEC. 2020 P A G E 15BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS
A M C P S T A F F & C O N S U LT A N T S / T H A N K Y O U
Susan A. Cantrell, RPh, CAE
Chief Executive Officer
Thank You
Phil Bongiorno
Vice President, Policy & Government Relations To our distinguished participants and guests.
Thomas Casey
Senior Policy & Government Relations Coordinator •
Liz Colangelo
Senior Manager, Business Strategies
About AMCP
AMCP is the professional association leading
Vyishali Dharbhamalla, PharmD
Manager, Professional Affairs the way to help patients get the medications
they need at a cost they can afford. AMCP’s
Abigail Fredenburg, MA
Director of Integrated Marketing diverse membership of pharmacists,
& Communications
physicians, nurses, and professionals in life
Julian Greer, CMP sciences and biopharmaceutical companies
Senior Manager, Meetings and Forums
leverage their specialized expertise in
Nicholas Ladikos, PharmD, BCPS, clinical evidence and economics to optimize
BCGP, BCIDP medication benefit design and population
Director of Professional Affairs
health management, and help patients access
Cate Lockhart, PharmD, PhD cost-effective and safe medications and other
Executive Director
therapies. AMCP members improve the lives of
Matt Lowe nearly 300 million Americans served by private
Vice President, Business Strategies
and public health plans, pharmacy
Noreen Matthews, BSN, MBA benefit management firms, and
Senior Business Consultant emerging care models.
Cynthia Reilly, MS, BS Pharm
Chief Operating Officer •
Terry Richardson, PharmD, BCACP AMCP Mission
Senior Pharmacist Consultant
To improve patient health by ensuring access
Ruby Singh, PharmD, BCPS
Vice President, Education and Training
to high-quality, cost-effective medications
and other therapies.
P A G E 16 AMCP PARTNERSHIP FORUM | DEC. 2020BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS
NOTES
AMCP PARTNERSHIP FORUM | DEC. 2020 P A G E 17AMCP | Academy of Managed Care Pharmacy Findings and recommendations from this
event will be published in an upcoming issue
675 N Washington Street | Suite 220 of AMCP’s Journal of Managed Care + Specialty
Alexandria, VA 22314
Pharmacy and will be widely disseminated to
703 684 2600 | www.amcp.org | @amcporg decision makers around the country.You can also read
